Orthodontic ApplianceNCT04338789
Accelerated Mandibular Molar Protraction: Piezocision at the Time of Molar Protraction or Later?
A study testing Piezocision in people with Orthodontic Appliance, run by Jordan University of Science and Technology.
Trial summary
This study was conducted to compare the rate of second molar protraction, level of Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque index, and periodontal pocket depth) and root resorption in patients treated by molar protraction with piezocision performed early at the time of… Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance
- What is being tested?
- Piezocision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 2 Dec 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range from 19 to 30 years
- Bilaterally extracted mandibular first molar (first molar extracted more than one year ago and with a residual extraction space of more than 6 mm).
- Class 1 malocclusion where molar protraction is indicated.
- All permanent teeth are present except for the extracted mandibular first molars.
- Healthy periodontium (gingival index score ≤ 2, plaque index score ≤ 2 and probing depth < 4mm)
Who cannot join
- Previous orthodontic treatment
- Any systemic disease
- Smoker
- Poor Oral hygiene
About this study
Official title: Mandibular Molar Protraction Assisted by Temporary Anchorage Device and Piezoelectric Corticotomy
This study was conducted to compare the rate of second molar protraction, level of Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque index, and periodontal pocket depth) and root resorption in patients treated by molar protraction with piezocision performed early at the time of protraction (Group 1), piezocision performed 3 months after molar protraction (Group 2), and no piezocision molar protraction (Group 3).
Read the detailed description
Detailed Description: Thirty-five subjects who presented with bilaterally extracted mandibular first molar were selected to participate in the study. The subjects were subdivided into one of 3 groups as follows: group 1 consisted of 20 subjects /20 molars where piezocision was performed immediately before molar protraction; group 2 consisted of 20 subjects/ 20 molars where molar protraction was carried on after 3 months of molar protraction with no piezocision; group 3 consisted of 20 subjects (40 molars) where protraction was carried out with no piezocision.
After reaching 0.019X0.025" SS arch wire, NiTi coil spring was used for space closure (protraction force was 150g) attached from the lower second molar hook to the head of the mini-screw. Piezocision was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm. Gingival crevicular fluid (GCF) sample was obtained from the mesiogingival side of the lower second permanent molar with use of Periopaper. GCF sample was repeated 1 day, 1 week and 4 weeks after molar protraction with piezocision or with no piezocision. Periodontal parameters were measured and lower molar root resorption was assessed using Perapical radiographs.
- Conditions
- Orthodontic Appliance
- Being tested
- Piezocision
- Keywords
- Piezocision, molar protraction, Accelerated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezocisionOther
Piezocesion was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | It consisted of 20 subjects with bilateral first molar extraction space where piezocesion was performed immediately before molar protraction on the left or right side of the patient. Receives: Other: Piezocision |
| Group 2 | Experimental | It consisted of 20 subjects with bilateral first molar extraction space where piezocesion was performed 3 months after molar protraction with no piezocision on the left or right side of the patient. Receives: Other: Piezocision |
| Group 3 | No intervention | It consisted of 20 subjects (40 molars) where molar protraction was performed with no piezocesion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of molar protraction
Measured in mm/month from dental casts
Measured: 1 year
Changes in the level of of Interleukin1-β
Detected in Gingival crevicular fluid (GCF). The periopaper was placed for 60 seconds in the mesiogingival sulcus of the lower second permanent molar and was transferred to an Eppendorf tube containing phosphate buffered saline.
Measured: 4 weeks
Secondary outcomes (2)
Periodontal parameters (Plaque, gingival health, periodontal pocket depth, alveolar bone height)
Plaque and gingival health are measured using plaque index and gingival index. pocket depth and alveolar height are measured in mm.
Measured: 1 year
Lower molar root resorption
Length of lower second molar roots in mm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start2 Dec 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic ApplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split mouth design where piezocision will be performed at the time of molar protraction on the right or left side of the bilateral first molar extraction subjects and 3 months of molar protraction on the other side. A third group of subjects will act as a control where molar protraction will be done with no piezocision. \- Comparison between the 3 groups of subjects; Early piezocision, late piezocision and no piezocision molar protraction groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Abu Alhaija, Jordan University of Science and Technology
- Investigators
- Elham S A Alhaija, PhD, Principal investigator, Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338789
- Sponsor's protocol ID
- 266/216
- Status last verified
- Apr 2020
- First submitted
- 25 Feb 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Molar Protraction Assisted by Temporary Anchorage Device and Piezoelectric Corticotomy
- ClinicalTrials.gov ID
- NCT04338789
- Acronym / sponsor ID
- 266/216
- Conditions
- Orthodontic Appliance
- Keywords
- Piezocision, molar protraction, Accelerated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 2 Dec 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to compare the rate of second molar protraction, level of Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque index, and periodontal pocket depth) and root resorption in patients treated by molar protraction with piezocision performed early at the time of protraction (Group 1), piezocision performed 3 months after molar protraction (Group 2), and no piezocision molar protraction (Group 3).
Detailed description
Detailed Description: Thirty-five subjects who presented with bilaterally extracted mandibular first molar were selected to participate in the study. The subjects were subdivided into one of 3 groups as follows: group 1 consisted of 20 subjects /20 molars where piezocision was performed immediately before molar protraction; group 2 consisted of 20 subjects/ 20 molars where molar protraction was carried on after 3 months of molar protraction with no piezocision; group 3 consisted of 20 subjects (40 molars) where protraction was carried out with no piezocision.
After reaching 0.019X0.025" SS arch wire, NiTi coil spring was used for space closure (protraction force was 150g) attached from the lower second molar hook to the head of the mini-screw. Piezocision was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm. Gingival crevicular fluid (GCF) sample was obtained from the mesiogingival side of the lower second permanent molar with use of Periopaper. GCF sample was repeated 1 day, 1 week and 4 weeks after molar protraction with piezocision or with no piezocision. Periodontal parameters were measured and lower molar root resorption was assessed using Perapical radiographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Split mouth design where piezocision will be performed at the time of molar protraction on the right or left side of the bilateral first molar extraction subjects and 3 months of molar protraction on the other side. A third group of subjects will act as a control where molar protraction will be done with no piezocision. - Comparison between the 3 groups of subjects; Early piezocision, late piezocision and no piezocision molar protraction groups.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: PiezocisionIt consisted of 20 subjects with bilateral first molar extraction space where piezocesion was performed immediately before molar protraction on the left or right side of the patient. |
| Group 2 | Experimental | Other: PiezocisionIt consisted of 20 subjects with bilateral first molar extraction space where piezocesion was performed 3 months after molar protraction with no piezocision on the left or right side of the patient. |
| Group 3 | No intervention | –It consisted of 20 subjects (40 molars) where molar protraction was performed with no piezocesion. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range from 19 to 30 years
- Bilaterally extracted mandibular first molar (first molar extracted more than one year ago and with a residual extraction space of more than 6 mm).
- Class 1 malocclusion where molar protraction is indicated.
- All permanent teeth are present except for the extracted mandibular first molars.
- Healthy periodontium (gingival index score ≤ 2, plaque index score ≤ 2 and probing depth < 4mm)
Key exclusion criteria (4 listed)
- Previous orthodontic treatment
- Any systemic disease
- Smoker
- Poor Oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiezocisionPiezocesion was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm. | Other | Group 1, Group 2 |
Primary outcome
Rate of molar protraction
Time frame: 1 year
Measured in mm/month from dental casts
Changes in the level of of Interleukin1-β
Time frame: 4 weeks
Detected in Gingival crevicular fluid (GCF). The periopaper was placed for 60 seconds in the mesiogingival sulcus of the lower second permanent molar and was transferred to an Eppendorf tube containing phosphate buffered saline.
2 secondary outcomes
Periodontal parameters (Plaque, gingival health, periodontal pocket depth, alveolar bone height)
Time frame: 1 year
Lower molar root resorption
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elham S A Alhaija, PhD principal investigator
Prof.
Questions about this trial
What is this clinical trial studying?
A study testing Piezocision in people with Orthodontic Appliance, run by Jordan University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of molar protraction (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.